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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-08-14 - 1990-08-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The test substance is applied to intact skin, but also to abraded skin. An occlusive dressing is used, instead of a semi-occlusive dressing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The test substance is applied to intact skin, but also to abraded skin. An occlusive dressing is used, instead of a semi-occlusive dressing.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Jeffcat DMP
Specific details on test material used for the study:
- Name of test material (as cited in study report): 6398-17-20
- Lot/batch No. 90-006
- Physical state: clear, pale yellow liquid
- Analytical purity: considered to be the responsibility of the sponsor
- Stability under test conditions: no apparent change in the physical state ot the test article during administration

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hare-Marland, Hewitt, NJ
- Age at study initiation: adult
- Weight at study initiation: 2.480 - 2.662 - 2.154 - 2.167 - 2.902 - 2.960 kg
- Housing: Rabbits were housed individually in cages sized in accordance with the ''Guide for the Care and Use of Laboratory Animals'' of
the Institute of Laboratory Animal Resources, National Research Council.
- Diet (e.g. ad libitum): Purina Lab Rabbit Ration HF, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum. Water is monitored for contaminants at periodic intervals according to Standard Operating Procedure PH-018.
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C (63-73°F)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h light, 12h dark


Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped; one site abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/site, 3 sites per animal

Duration of treatment / exposure:
4h (upper dorsal site) and 24h (lower dorsal sites)
Observation period:
Upper dorsal site: at 30min, 60min, 24h ,48h, 72h, daily from Day 4 to Day 14 after patch removal
Lower dorsal sites: at 24h, 48h and 72h, and daily from Day 4 to Day 14 after application of the test material
Number of animals:
6 (3F and 3M)
Details on study design:
TEST SITE
- Area of exposure: upper dorsal trunk (intact), lower dorsal trunk (1 intact and 1 abraded site), clipped free of fur
- Type of wrap if used: gauze patch, rubber dam and an elastic bandage to retard evaporation

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with water and gauze
- Time after start of exposure: 4h (upper sites) and 24h (lower sites)


SCORING SYSTEM: observation
Draize Evaluation of Dermal Irritation, Primary Dermal Irritation Index and Modified Primary Dermal Irritation Index

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
7.92
Max. score:
8
Remarks on result:
other: severe dermal irritation
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
other: 30-60min, 24h, 48h, 72h and daily until Day 14
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
, 4h and 24h exposure) (14 days observation)
Remarks on result:
other: at all sites: severe erythema and necrosis
Irritation parameter:
edema score
Basis:
animal: 6/6
Time point:
other: 24h, 48h, 72h and daily until Day 14
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
, 4h and 24h exposure) (14 days observation)
Remarks on result:
other: at all sites: severe edema, necrosis
Irritant / corrosive response data:
All animals scored 4 (severe erythema and severe edema) which remained present in all animals during whole observation period (up to 14days).

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
The test article was considered to be a severe dermal irritant at both 4 and 24 hour exposures. Necrosis of the skin at each application site was observed at the 24, 48 and 72 hour observation periods and on Days 4 through 14. The study was terminated following the Day 14 observation period. (Primary Irritation Index, according to Draize = 7.92, modified Primary Irritation Index = 8.00). Based on these results and according to the criteria laid down in the CLP Regulation, the substance is considered classified as corrosive to the skin category 1C.